FDA 510(k) Application Details - K093400

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K093400
Device Name	Syringe, Piston
Applicant	UNILIFE MEDICAL SOLUTIONS LIMITED 633 LOWTHER RD. LEWISBERRY, PA 17339 US Other 510(k) Applications for this Company
Contact	MELISSA L DEHASS Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2009
Decision Date	04/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review